Z-1373-2012

Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518...

Name: Z-1373-2012 Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518...
Creator: Beckman Coulter Inc.
Published: 2008-09-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-09-11 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF Wash Buffer REF 81907, Part Number... on 2008-09-11. The reason FDA records is "The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1373-2012
Status: Terminated
Initiated: 2008-09-11
Posted: 2012-04-06
Terminated: 2012-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF Wash Buffer REF 81907, Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.
Quantity in commerce: 2948 units total (2762 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: Part Number: A19889, Access APF Wash Buffer REF 81907 Lot Number: 714944, 717432, 720808, 821426, 823659. Part Number: A45144, Access APF Wash Buffer REF A16792 Lot Number: 714939, 717433, 720811, 821429, 823661.

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)